Which generalized anxiety disorder drugs are in Phase 3?

Phase 3 (or later) programs for generalized anxiety disorder include Lysergide D-tartrate (MM120 / LSD).

What are the next generalized anxiety disorder trial readouts?

Upcoming catalysts include Lysergide D-tartrate (MM120 / LSD) (Sep 2026), PT00114 (fourth quarter 2026), Luvesilocin (RE104) (February 2027) and ITI-1284 (deulumateperone) (Mid-2027).

How many clinical trials are recruiting for generalized anxiety disorder?

21 drug-interventional generalized anxiety disorder trials are currently recruiting participants, out of 185 registered interventional trials.

Anxiety & Trauma Disorders

Generalized anxiety disorder drug pipeline

ICD-11 6B00
MeSH D000098647

6 compounds from 6 companies are in active clinical development for generalized anxiety disorder, including 1 at Phase 3 or beyond.

6Compounds

6Companies

1Phase 3+

6Upcoming readouts

21Trials recruiting

Phase 11

PT00114Protagenic Therapeutics, Inc.

Phase 23

Phase 2/31

Ulotaront (SEP-363856)Otsuka Pharmaceutical Co., Ltd.TAAR1 Agonist

Phase 31

Lysergide D-tartrate (MM120 / LSD)Definium Therapeutics, Inc.5-HT2A Partial agonist

Mechanisms: Psychedelic (3) · Small molecule (2) · Peptide (1)

Pipeline data compiled September 2026 · every fact sourced.

Upcoming readouts & recent results

Sep 2026AnticipatedLysergide D-tartrate (MM120 / LSD)Topline data
Panorama, the second Phase 3 study of DT120 ODT in GAD: topline expected September 2026 ↗
fourth quarter 2026AnticipatedPT00114Regulatory
US IND submission for PT00114 in generalized anxiety disorder targeted before end of 2026, following FDA Type B pre-IND written responses that identified no clinical-hold issues; first patient dosing targeted 1H 2027. ↗
February 2027AnticipatedLuvesilocin (RE104)Registry resultsNCT07489651
ClinicalTrials.gov estimated primary completion of RECLAIM (NCT07489651): February 2027, with estimated study completion April 2027. ↗
Mid-2027AnticipatedITI-1284 (deulumateperone)Topline dataNCT06480383
Anticipated Phase 2 topline for adjunctive ITI-1284 in GAD (NCT06480383); primary completion targeted June 2027. ↗
Mid-2027AnticipatedITI-1284 (deulumateperone)Topline dataNCT06701903
Anticipated Phase 2 topline for monotherapy ITI-1284 in GAD (NCT06701903); primary completion targeted June 2027. ↗
2Q 2027AnticipatedLuvesilocin (RE104)Topline dataNCT07489651
Topline results from the RECLAIM Phase 2 trial of a single 30 mg subcutaneous dose of RE104 versus placebo in generalized anxiety disorder (primary endpoint: change from baseline in HAM-A total score at Week 4), expected 2Q 2027. ↗
2026-08-12ReportedLysergide D-tartrate (MM120 / LSD)Topline datamet
Phase 3 Voyage topline: single-dose DT120 ODT meets primary in GAD (HAM-A −5.4 pts vs placebo at Week 12, p<0.0001) ↗
2025-12-09ReportedPT00114Topline datamet
Phase 1 multiple-dose topline: PT00114 well tolerated across all dose ranges; no serious adverse events; all participants completed dosing; adverse events consistent with an injectable peptide (injection-site reactions). ↗
2024-05-22ReportedPT00114Topline datamet
Phase 1 single-ascending-dose complete results: zero clinically-relevant adverse events in 30 subjects across five cohorts at subcutaneous doses up to 1,000 micrograms. ↗

See the full catalyst calendar →

Compounds in development (6)

Compound	Company	Phase	Status	Mechanism
Lysergide D-tartrate (MM120 / LSD)BTD	Definium Therapeutics, Inc.	Phase 3	Active	5-HT2A Partial agonist
Ulotaront (SEP-363856)	Otsuka Pharmaceutical Co., Ltd.	Phase 2/3	Completed	TAAR1 Agonist
CYB004 (deuterated DMT)	Helus Pharma	Phase 2	Completed	5-HT2A Agonist
ITI-1284 (deulumateperone)	Johnson & Johnson	Phase 2	Recruiting	5-HT2A Antagonist
Luvesilocin (RE104)	Reunion Neuroscience Inc.	Phase 2	Recruiting	5-HT2A Agonist
PT00114	Protagenic Therapeutics, Inc.	Phase 1	Active	Peptide

Trials recruiting now (21)

21 drug-interventional generalized anxiety disorder trials recruiting now, of 185 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
dexmedetomidine, Esketamine
Second Affiliated Hospital of Wenzhou Medical Universityn=80China · 2 sitesStarted Mar 2025NCT06853431
Phase 4Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
L-methylfolate
Queen's Universityn=10Canada · 1 siteStarted Oct 2024NCT06218030
Phase 4Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
sertraline
University of Cincinnatin=150United States · 1 siteStarted Nov 2019NCT04221997
Phase 3Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
Pharmacological conventional treatment
Psicofarma, S.A. De C.V.n=162Mexico · 1 siteStarted Mar 2026NCT07477990
Phase 3Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
Low-Dose Cannabidiol, Placebo Matched to Moderate-Dose Cannabidiol, Moderate-Dose Cannabidiol, Placebo Matched to Low-Dose Cannabidiol
Wayne State Universityn=90United States · 1 siteStarted Nov 2025NCT07123467
Phase 3Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD
Buagafuran capsules, 15mg/ capsule, Buagafuran capsules mimic, 0mg/ capsule
Beijing Union Pharmaceutical Factory Ltdn=504China · 1 siteStarted Jul 2023NCT06243640
Phase 3Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD
Buagafuran capsules, 15mg/ capsule, Buspirone tablets, 5mg/ tablet, Buagafuran capsules mimic, 0mg/ capsule, Buspirone tablets mimic, 0mg/ tablet
Beijing Union Pharmaceutical Factory Ltdn=410China · 1 siteStarted Jul 2023NCT06243614
Phase 3Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Shugan Jieyu Capsules, Shugan Jieyu Capsules Placebo
Sichuan Jishengtang Pharmaceutical Co., Ltd.n=495China · 1 siteStarted Apr 2023NCT05772104
Phase 2A Phase 2a Efficacy, Safety, Tolerability, and PK Study of SYT-510 in Participants With Generalized Anxiety Disorder
SYT-510, Placebo
Synendos Therapeutics AGn=24United Kingdom · 1 siteStarted Apr 2026NCT07478744
Phase 2A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder — RECLAIM
RE104 for Injection, Placebo
Reunion Neuroscience Inc.n=64United States · 12 sitesStarted Apr 2026Tracked: Luvesilocin (RE104)NCT07489651
Phase 2Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder
Crisugabalin 20mg bid, Venlafaxine-XR 75mg bid, Crisugabalin capsules mimic 0mg/capsule bid
Anhui Medical Universityn=216China · 1 siteStarted Oct 2025NCT07330648
Phase 2Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder
Psilocybin (drug)
Queen's Universityn=50Canada · 1 siteStarted May 2025NCT06969170

Showing the 12 most advanced of 21 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for generalized anxiety disorder?: 6 compounds from 6 companies are in active clinical development for generalized anxiety disorder, including 1 at Phase 3 or beyond.
Which generalized anxiety disorder drugs are in Phase 3?: Phase 3 (or later) programs for generalized anxiety disorder include Lysergide D-tartrate (MM120 / LSD).
What are the next generalized anxiety disorder trial readouts?: Upcoming catalysts include Lysergide D-tartrate (MM120 / LSD) (Sep 2026), PT00114 (fourth quarter 2026), Luvesilocin (RE104) (February 2027) and ITI-1284 (deulumateperone) (Mid-2027).
How many clinical trials are recruiting for generalized anxiety disorder?: 21 drug-interventional generalized anxiety disorder trials are currently recruiting participants, out of 185 registered interventional trials.